The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ...

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...